The Role
- Technical Writer
- Limerick – Onsite
- Permanent or Contract Opportunity
Role Brief
Perform all technical writer related tasks necessary for the creation and maintenance of quality GMP documentation in support of the Technical Operations Engineering and Automation Department.
Essential Duties and Responsibilities
– Collaborate with subject matter experts and key functional department personnel to
ensure timely development and accurate content of GMP documents (e.g. standard operating procedures, system design documents, and work instructions)
– Perform retrospective assessment of computerized system administration activities and author the resulting reports.
– Maintain an awareness and understanding of current site document requirement, document control procedures, and good documentation best practices. Review internal
GMP documents to ensure they are compliant with these expectations and suggest
improvements.
– Manage and coordinate activities related to document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement.
– Conduct compliance review of electronic work tickets for adherence to Good
Documentation Practices/Requirements
– Facilitate cross-functional collaboration of cGMP documentation with technical experts
and stakeholders to reach consensus and ensure document approval timelines meet
business needs.
– Own and/or support GMP document-related Change Controls/CAPAs.
Skills Brief
– Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards,GAMP5, and Documentation Management/Life Cycle guidance
– Applies excellent collaboration skills, via multiple communication types, in a steady paced environment
– Strong writing and proofreading skills in a technical and scientific capacity.
– Ability to organize and author technically complex information into laymen suitable documentation.
– Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes.
– BS/BA in Life Sciences, Engineering, English or related field or equivalent combination of education and experience.
Person Brief
Candidates must have a relevant science or engineering tertiary qualification with a minimum of 2 years’ experience in the medical devices, pharmaceutical or life sciences industry with strong experience in Equipment & Process Validation. The ideal candidate will have excellent collaboration and communication skills, with a demonstrated understanding of manufacturing processes and related process equipment. In addition to this, strong attention to detail and an excellent understanding of validation concepts and documentation is required.
The candidate should be based in Ireland and able to commute onsite as required.
Opportunity Brief
This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.
Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.
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